Problem Formulation,

for Ecological Risk Assessment,

for Fluazinam

June15, 2009

Environmental Fate and Effects Division

Office of Pesticide Programs

U.S. Environmental Protection Agency
2

Table of Contents

1. Purpose.................................................................................................................................... 3

2. Problem Formulation .............................................................................................................. 3

2.1 Nature of Regulatory Action................................................................................................ 3

2.2. Previous Risk Assessments.................................................................................................. 3

3. Stressor Source and Distribution ............................................................................................ 3

3.1. Mechanism of Action.......................................................................................................... 3

3.2. Overview of Pesticide Usage .............................................................................................. 5

3.3. Environmental Fate and Transport...................................................................................... 8

4. Receptors............................................................................................................................... 13

4.1. Aquatic and Terrestrial Effects......................................................................................... 13

4.2. Incident Database Review............ Error! Bookmark not defined.Error! Bookmark not 

defined.

4.3. Ecosystems Potentially at Risk ......................................................................................... 18

6. Conceptual Model.............................................................................................................. 19

6.1. Risk Hypothesis............................................................................................................... 19

6.2. Conceptual Diagram ........................................................................................................ 20

7. Analysis Plan ..................................................................................................................... 21

7.1. Stressors of Concern ......................................................................................................... 22

7.2. Measures of Exposure....................................................................................................... 22

7.3. Measures of Effect ............................................................................................................ 23

7.4. Integration of Exposure and Effects ................................................................................. 24

7.5. Deterministic and Probabilistic Assessment Methods...................................................... 24

7.6. Endangered Species Assessments..................................................................................... 25

7.7. Drinking Water Assessment ............................................................................................. 25

7.8. Preliminary Identification of Data Gaps........................................................................... 25

7.8.1. Fate............................................................................................................................. 25

7.8.2 Effects......................................................................................................................... 27

8. References................................................................................................................................ 31

Appendix A. SRRD data request justification tables.................................................................. 32
3

1. Purpose

The purpose of this problem formulation is to provide the foundation for the ecological risk 

assessment being conducted for fluazinam. As such, it articulates the purpose and objectives of 

the risk assessment, evaluates the nature of the problem, and provides a plan for analyzing the 

data and characterizing the risk (EPA, 1998). 

2. Problem Formulation

2.1. Nature of Regulatory Action

This report summarizes the Environmental Fate and Effects Division’s (EFED) Problem 

Formulation for the Registration Review of fluazinam. Previous risk assessments were

completed for the uses of the chemical, through 2007, which serve as the basis for this 

assessment. 

2.2. Previous Risk Assessments

In 2007, two risk assessments were issued for fluazinam. One was an IR-4 petition (dated 

5/16/2007; DP Barcodes 338293 and 338294) for uses on legume vegetable Crop Subgroup 6A, 

bushberry Crop Subgroup 13B, brassica leafy vegetable Crop Group 5, ginseng, dry bean, lima 

bean and succulent bean Crop Subgroup 6B. Chronic LOCs were exceeded for avian (RQs 

ranged from 3.40 to 0.06) and mammalian (RQs ranged from 6.80 to 0.12) endangered and nonendangered species. In addition, there was acute and chronic risk indicated for aquatic 

organisms. Since fluazinam is practically nontoxic to honey bees, no labeling precautions were 

required. Risks to plants were below LOCs.

In addition, a risk assessment was issued for the proposed aerial use of fluazinam on potatoes

(dated 11/21/07; DP Barcode 342007) (previously, only ground applications were allowed). In 

the risk assessment, it was found that chronic LOCs were exceeded for avian (RQs ranged from 

1.0 to 1.5) and mammalian (RQs ranged from 0.2 to 3.0) endangered and non-endangered 

species. Chronic risk was indicated for endangered and non-endangered freshwater fish, 

estuarine/ marine invertebrates and estuarine/ marine benthic organisms. Acute LOCs were 

exceeded for endangered and non-endangered estuarine/ marine benthic organisms. When 

comparing ground applications, and aerial applications with and without using a buffer, 

generally, ground applications produced the lowest risk while aerial applications using buffer 

zones had RQs that were slightly less than aerial applications without buffers. As in the previous 

case, no labeling precautions were required to honey bees. Risks to plants were below LOCs.

3. Stressor Source and Distribution

3.1. Mechanism of Action
4

Fluazinam, CAS Name: 3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5- (trifluoromethyl)-2-pyridinamine, and IUPAC Name: 3-chloro-N-(3-chloro-5-trifluoromethyl-2-

pyridyl)-α,α,α-trifluoro-2,6-dinitro-p-toluidine, has a CAS Number of 79622-59-61 and a PC 

Code of 129098. It is a pyridine (dinitroaniline) fungicide. The structure consists of one phenyl 

ring with two nitro groups, and a pyridine ring. Both rings have a trifluoromethyl group. The 

rings are attached by an amine group. The product name is Omega 500F Agricultural Fungicide 

(EPA Reg. No. 71512-1). It contains 40.0% fluazinam. Fluazinam is a protectant and contact 

fungicide. According to the Fungicide Resistance Action Committee (FRAC) classification 

scheme of fungicides, fluazinam belongs to the chemical group of 2,6-dinitroanilines and is 

classified as FRAC numerical code 29, according to the mode of action, which is inhibition of 

respiration. Fluazinam is an uncoupler of oxidative phosphorilation in the respiration chain 

involving protonation/ deprotonation (it inhibits fungal respiration, and the production of energy

within the fungus). Fluazinam belongs to a chemical group classified as a multi-site fungicide 

(chemicals which act as general toxophores with several sites of action). Table 1 shows the 

chemical structures of fluazinam and various of its transformation products (CAPA, DAPA, 

AMPA, DCPA, HYPA, G-504 and MAPA). It is noted that all these chemicals (except for G504, which is a tricyclic compound) are structurally similar (they have the same backbone 

structure). They are also considered stressors.

Table 1. Fluazinam and Various Transformation Products

Common Name Chemical Name Structure

Fluazinam CAS Name: 3-chloro-N-[3-chloro-2,6-

dinitro-4-(trifluoromethyl) phenyl]-5-

(trifluo-romethyl)-2-pyridinamine;

IUPAC Name: 3-chloro-N-(3-chloro-5-

trifluoromethyl-2- pyridyl)-α,α,αtrifluoro-2,6-dinitro-p-toluidine

CAPA 3-chloro-6-(3-chloro-2,6-dinitro-4-

trifluoromethyl anilino)nicotinic acid;

5-chloro-6-(3-chloro-α,α,α-trifluoro2,6-dinitro-p-toluidino)nicotinic acid

N

H

N

O2N

O2N

Cl

CF3

Cl

HOOC

DAPA 3-chloro-N

4

-(3-chloro-5-

trifluoromethyl-2-pyridyl)-α,α,αtrifluorotoluene-3,5,5-triamine; 3-

chloro-2(2,6-diamino-3-chloro-α,α,αtrifluoro-p-toluidino)-5-

(trifluoromethyl) pyridine

N

H

N

H2N

CF3

Cl

H2N

Cl

F3C

DAPA
5

Table 1. Fluazinam and Various Transformation Products

Common Name Chemical Name Structure

AMPA 2-(6-amino-3-chloro-α,α,α-trifluoro-2-

nitro-p-toluidino)-3-chloro-5-

(trifluoromethyl)pyridine

N

H

N

O2N

H2N

Cl

CF3

Cl

F3C

DCPA 6-(4-carboxy-3-chloro-2,6-

dinitroanilino)-5-chloronicotinic acid

N

H

N

O2N

COOH

Cl

O2N

Cl

HOOC

DCPA

MAPA 3-chloro-N

4

-(3-chloro-5-

trifluoromethyl-2-pyridyl)-5-nitroα,α,α-trifluoro-toluene-3,4-diamine

N

H

N

H2N

O2N

Cl

CF3

Cl

F3C

HYPA,

Compound XII

5-[[3-chloro-5-(trifluoromethyl-2-

pyridyl]amino]-α,α,α-trifluoro-4,6-

dinitro-o-cresol

N

H

N

O2N

CF3

HO

O2N

Cl

F3C

G-504 4,9-dichloro-6-nitro-8-

(trifluoromethyl)pyrido-[1,2-α]-

benzimidazole-2-carboxylic acid

N

N

O2N

CF3

Cl

Cl

HOOC

3.2. Overview of Pesticide Usage

A summary table of all use patterns for fluazinam follows (Table 2).
6

Table 2. Summary use information for fluazinam (based on Omega 500F label, EPA Reg. No. 71512-1).

USE

SINGLE APP. 

RATE (lb. 

a.i./A)

NUMBER 

OF APPS.

SEASONAL 

APP. RATE 

(lb. a.i./A)

INTERVAL 

BETWEEN 

APPS. (days) APP. METHOD PHI (days)

Peanut 0.52-1.04 2 2.09 21 Ground, 

Sprinkler 

irrigation

Do not 

apply w/in 

30 d of 

threshing 

for harvest

Potato 0.18-0.26 7 1.82 7 Aerial, 

Ground,

Sprinkler 

irrigation

14

Crop Subgroup 6A, 

Edible-Podded Legume 

Vegetables except peas, 

such as, but not limited to: 

Phaseolus spp. Such as: runner 

bean, snap bean, wax bean; 

Vigna spp. Such as: asparagus 

bean, Chinese longbean, moth 

bean, yardlong bean; jackbean, 

and sword bean

0.26-0.44 2 0.91 7 Ground, 

Sprinkler 

irrigation

14

Succulent Bean Crop 

Subgroup 6B (such as, but

not limited to lima bean and 

broad bean)

0.26-0.44 2 0.91 7 Ground, 

Sprinkler 

irrigation

14

Dry Bean Crop Subgroup 

6C, except Peas and 

Soybeans (such as, but not 

limited to dried cultivars of 

bean: Lupinus spp.; Phaseolus 

spp, such as kidney beans, dry 

lima bean, navy bean, pinto 

bean; Vigna spp., such as adzuki 

bean; and broad bean, such as 

lablab bean)

0.26-0.44 2 0.91 7 Ground, 

Sprinkler 

irrigation

30

Crop Subgroup 13-07B, 

Bushberry, such as, but not 

limited to: Aronia berry, 

blueberry (highbush and 

lowbush), Chilean guava, 

currant (Buffalo, black, red, and 

Native), elderberry, European 

barberry, gooseberry, highbush 

cranberry, honeysuckle, 

huckleberry, jostaberry, 

juneberry, lingonberry, salal, 

and sea buckthorn

0.65 6 3.90 7 Ground 30
7

Table 2. Summary use information for fluazinam (based on Omega 500F label, EPA Reg. No. 71512-1).

USE

SINGLE APP. 

RATE (lb. 

a.i./A)

NUMBER 

OF APPS.

SEASONAL 

APP. RATE 

(lb. a.i./A)

INTERVAL 

BETWEEN 

APPS. (days) APP. METHOD PHI (days)

Crop Group 5, Brassica 

(Cole) Leafy Vegetables, 

such as, but not limited to: 

broccoli; broccoli raab (rapini); 

Chinese cabbage (napa); 

cauliflower; collards, kale; 

mizuna; mustard spinach; turnip 

greens; Chinese broccoli; 

Brussels sprouts; Chinese 

cabbage (bok choy); Chinese 

mustard cabbage; cavalo 

broccoli; kohlrabi; mustard 

greens; rape greens

[Transplant 

6.45 fl oz/100 

gal or 

presumably 

0.64 lb a.i./A]

Soil incorporation 1.36 at 

a soil depth 

of 6-8 in

1 2.00 N/A Soil drench 

after 

transplanting

or soil 

incorporation

(transplant 

the seedlings 

into the 

treated band

20;

50 for 

heading 

vegetables 

such as 

cabbage 

and 

broccoli

Ginseng 0.52-0.78 4 3.13 7 Ground 30

Fluazinam may be applied through sprinkler irrigation (through center pivot, motorized lateral 

move, traveling gun, solid set or portable1irrigation systems); however, it can also be soil 

incorporated before transplant, for Crop Group 5, brassica (cole) leafy vegetables, in soils with 

low infiltration rates.

The label requires a buffer zone of 25 ft within permanent bodies of water (lakes, reservoirs, 

rivers, permanent streams, marshes or natural ponds, and estuaries) so as to allow growth of a 

vegetative filter strip. The product should not be applied by aerial equipment within 150 ft of 

estuarine/ marine areas (aerial applications are currently allowed only for potatoes). The product 

does not require a similar buffer zone for aerial applications on freshwater bodies of water (for 

freshwater bodies of water, a 25-ft buffer applies).

The SLUA summary for fluazinam is as follows (Table 3):

Table 3. Screening-Level Estimates of Agricultural Uses of Fluazinam (SLUA, 10/03/08)

Crop lb a.i.

Percent (%) Crop Treated

Average Maximum

Peanuts 10,000 <2.5 5

Potatoes 60,000 10 20

The sources of the SLUA include the USDA-NASS (2001-2006), Private Pesticide Market Research (2001-2007), 

the National Use Database (NPUD 2002) of the CropLife America Foundation and California Department of 

Pesticide Regulation (CDPR) data. The information is amalgamated and put in a public releasable format.

The U.S. Geological Survey (USGS) pesticide use map (Fig. 1) shows regional scale patterns in 

use intensity within the United States. The USGS pesticide maps are based on State level 

estimates of pesticide use rates for individual crops, which have been compiled by the National 

Center for Food and Agricultural Policy (NCFAP) for 1999 through 2004, and on the 2002

 

1 Wheel move, side roll, end tow, or hand move portable irrigation systems.
8

Census of Agriculture for county crop acreage crop. It is noted that based on the uses at the time

there were already potential estuarine/ marine areas of concern in the East coast.

The only uses for fluazinam available through the time covered by the map were peanuts and 

potatoes. Based on the map information, potatoes used roughly two thirds of the fluazinam 

applied (>63,000 lb), while peanuts covered roughly one third (>31,000 lb).

Fig. 1. Use of Fluazinam in 2002.

Note of Caution: The pesticide use maps available from the web (http://water.usgs.gov/nawqa/pnsp/usage/maps/compound_listing.php?year=02 )

show the average annual pesticide use intensity expressed as average weight (in pounds) of a pesticide applied to each square mile of agricultural 

land in a county. The area of each map is based on state-level estimates of pesticide use rates for individual crops that were compiled by the CropLife 

Foundation, Crop Protection Research Institute during based on information collected during 1999 through 2004 and on 2002 Census of Agriculture 

county crop acreage. The maps do not represent a specific year, but rather show typical use patterns over the five year period 1999 through 2004. Use 

intensity rates are expressed as the pounds applied per square mile of mapped agricultural land in a county. The area of mapped agricultural land for 

each county was obtained from an enhanced version of the 1992 USGS National Land Cover Data (NLCD). The key limitations of the data used to 

produce these maps include the following: (1) state use coefficients represent an average for the entire state and consequently do not reflect the local 

variability of pesticide management practices found within states and counties, (2) pesticide use estimates are not for a specific year, but represent 

typical use patterns for the five year period, (3) state pesticide use coefficients may not have been available for all states where a pesticide may have 

been applied to agricultural land, and therefore, are not displayed on the maps, (4) the county crop acreage is based on the 2002 Census of Agriculture 

and may not represent all crop acreage because of Census nondisclosure rules, and (5) agricultural land area used to calculate the pesticide use 

intensity and display the data was derived from 30-meter satellite remote sensing data that may over estimate or underestimate the actual agricultural 

land area. The maps are not intended for making local-scale estimates of pesticide use, such as estimates at the county level. Please refer to Method 

for Estimating Pesticide Use for a detailed discussion of how the pesticide use data were developed.

3.3. Environmental Fate and Transport

A summary of physicochemical and environmental fate/transport properties of fluazinam is 

included in Table 4.
9

Table 4. Summary of Various Physicochemical and Environmental Fate Properties of Fluazinam

Parameter Value Reference/Comments *

Selected Physicochemical Parameters

Water Solubility (25oC) 0.025 mg/L @ pH 5.5, 0.071 @ pH 7.0 MRID 42208403

Vapor pressure 8.25x10-6 mm Hg MRID 42248403

Molecular Formula C13H4Cl2F6N4O4

Molecular Weight 465.1 g/mol

CAS No. 79622-59-6

CAS name 3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-(trifluoromethyl)-2-

pyridinamine

IUPAC name 3-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-2,6-dinitro-ptoluidine

Henry’s Law Constant 6.73 x 10-7atm-m

3

/mol at pH 7 PMRA Reg. Note REG2003-12

Octanol/Water Partition, Log KOW 3620, 3.56 @20°C MRID 42248403

Persistence: 

 Fluazinam Fluaz.+Degradates 

Hydrolysis t1/2 pH 5

pH 7

pH 9

stable

42 days

6 days

stable

stable

stable

MRID 42208412 (a)

Photolysis t1/2 in water 2.5 days, dark 

control ≈stable

one degradate (G504)MRID 44807312, 43521009, 45584204

(a)

on soil 35.0 days, value 

corrected for dark 

control

degradates at 

≤10% of the 

applied

MRID 44807313, 45584204 (a)

Soil metabolism Aerobic t1/2 114-132 days for 

samples treated at 

1 kg/ha (5.56 ppm)

degradates at 

≤10% of the app.; 

HYPA was 11.4% 

at 30 days (for soil 

treated at 5 kg/ha)

MRID 42208413, 42208414 (a)

Soil metabolism Anaerobic t1/2 SL flooded at time 

0, 4 days; SL 

flooded at 30 days, 

32 days

HYPA was 11.0% 

at 60 days for the 

spl. flooded at 30 

days. MAPA was 

up to 29.8% for the 

sample flooded at 

time 0.

MRID 42208413, 42208414 (s)

Aquatic metabolism Aerobic DT50 4.0-7.4 hours 51-71 days MRID 44807314 (a)

Aquatic metabolism Anaerobic t1/2 ≈ 1⁄3 day (or 

approximately 8 

hours)

stable MRID 43521010 (a)
10

Table 4. Summary of Various Physicochemical and Environmental Fate Properties of Fluazinam

Parameter Value Reference/Comments *

Mobility/Adsorption-Desorption

Batch Equilibrium - Unaged

Batch Equilibrium HYPA

Batch Equilibrium CAPA

Aged Soil Column Leaching

4 soils KF=11-44 KFOC=1700-2300

 KF, des=34-507 KFOC, des=7000-19900

6 soils Kd=6.6-51 KOC=640-3200

 KF=4.3-26 KFOC=450-1700

Increasing adsorption w. increasing pH

4 soils KF=4.9-67 KFOC=1289-3784

Studies on HYPA and CAPA were 

conducted w. sterile soils.

0.66% in leachate

MRID 42248628, 42974913 (a)

MRID 43528201 (a)

MRID 44807315 (s)

MRID 42208415 (a)

Field Dissipation

Terrestrial Dissipation

t1/2 in soil surface layer

Range from 9 to 49 days: Ephrata, 

WA: DT50~9 days loamy sand, pinto 

beans; Kempton, ND: half-life=49 

days, sandy loam, beans; Porterville, 

CA: half-life=20 days, loamy sand, 

beans; Montezuma, GA The 

degradation was biphasic.

MRID 44807318, 44807320, 44807316 

(s)

Bioaccumulation

Accumulation in Fish, max. BCF 273-348 X for fillet portion

960-1220 X for whole fish

1410-1850 X for non-edible

~67% of the residues eliminated from the 

fillet during the 21-day depuration phase

MRID 43521012 (a)

(a) = acceptable or core study that fulfills guideline requirement; (s) = supplemental study; (u) = unacceptable study Where 

two values are stated, they may correspond to two radiolabel positions.

Fluazinam appears to degrade at moderate to low rates in aerobic soils (132 days), but it is more 

rapidly transformed into other compounds of similar backbone structure in high pH solutions (6 

days at pH 9) or in aerobic (≤7.4 hr) or anaerobic aquatic (~8 hr) media. The transformation 

products of fluazinam appear to be relatively persistent under most conditions. Fluazinam may 

be photolysed relatively rapidly in water (2.5 days) to form a tricyclic compound (G-504). The

total fluazinam residues (fluazinam and its transformation products) are persistent in most 

environments (stable to hydrolysis at all pHs, aerobic aquatic metabolism 51-71 days, relatively

stable in anaerobic aquatic environment) and are likely to reach aquatic media as a totality

through runoff. Since fluazinam does not alter substantially its backbone structure in the 

environment, but instead, goes through slight transformations of functional groups, EFED 

considered parent and transformation products together when making assessments. While the 

parent and two transformation products, HYPA and CAPA, have relatively low mobility, 

indicating low potential for ground water contamination, there is uncertainty about the other 

transformation products and further information on them was required in a new Terrestrial Field 

Dissipation studies. Two such studies (MRID#’s 45584207 and 45584208) are currently in 

review. Based on the properties of the chemical, applications of fluazinam are likely to reach the 
11

target (the crop), but drift is also possible. The total residues of fluazinam may reach adjacent 

bodies of water via runoff events and may be persistent. The chemical has a low vapor pressure 

(8.25x10-6 mm Hg), and a relatively low Henry’s Law constant (6.73 x 10-7atm-m

3

/mol). Due to 

the fact that it appears to show short half lives in aquatic media, and it binds to soils, EFED 

believes that the chemical would not volatilize substantially.

Hydrolysis 

The hydrolysis of fluazinam is pH dependent. It was relatively stable at pH 5, and hydrolyzed 

with half-lives of 42 and 6 days at pH’s of 7 and 9, respectively. The major degradate was 

CAPA.

Photolysis 

Fluazinam photolyses in aqueous solutions, mainly to G-504, a tricyclic compound, and possibly

one or more other unidentified products. The half-life obtained in the study was 2.5 days. The 

soil photolysis, on the other hand, the half-life was 22 days (compared to 69 days for the dark 

control). The dark control corrected half-life is 35 days.

Metabolism 

The metabolism of fluazinam appears to be moderate in a sandy loam soil treated at 1 kg/ha

(5.56 ppm) (DT50 ≤ 30 days). The calculated half-life (linear regression, assuming first order 

kinetics) was about 114-132 days, which is in agreement with the fact that after 361 days, 6.8 

and 9.5% of the applied fluazinam remained intact for the 14C-Pyridyl and 14C-Phenyl labels, 

respectively; no major metabolites were observed. The sandy loam treated at 5 kg/ha yielded a 

half-life of 227 days; in this case, Compound XII (HYPA) was observed at up to 11.4% at 30 

days posttreatment. A loamy sand treated at 1 kg/ha yielded a half-life of 165 days with no 

major metabolites. No major degradation products were observed in the samples treated at 1 

kg/ha, but a major fraction (~41%) was bound material at the end of the study (day 361).

Sediment/Water Systems 

The aerobic aquatic and the anaerobic aquatic metabolism studies resulted in very short halflives (≤8 hours in both studies). In addition, in such studies, various metabolites were formed. 

All the major transformation products observed have structures that resemble the structure of the 

parent. The sum of the amount of the parent concentration plus the concentrations of the 

transformation products (total fluazinam residues) decreases very slowly under both aerobic 

(half-lives 51-71 days) and anaerobic (relatively stable) aquatic conditions. The major 

transformation products observed in these studies include DAPA, SDS-67200, AMPA, DCPA, 

and CAPA.

Mobility 

In batch equilibrium studies, fluazinam is slightly mobile in four soils tested. KFOC values 

ranged from 1705-2316. Similarly, an available soil column leaching study of aged fluazinam 

indicated low mobility of the residues of fluazinam. Less than 1% of the applied radiocarbon 

was found in the leachates and >>80% remained at the top of the soil columns. There is mobility

information for two of the transformation products of fluazinam: HYPA and CAPA. Of them, 

HYPA appeared to be moderately to slightly mobile (KFOC=450-1700, 6 soils), and CAPA 
12

appeared to be slightly mobile, but generally less mobile than the parent (KFOC=1289-3784, 4 

soils). The latter two batch/equilibrium studies were conducted on sterile soils.

Field Dissipation

Four terrestrial field dissipation studies were submitted by the registrant. Such studies were 

found to provide only limited supplemental information. In particular, the data about the 

degradates is very questionable due to poor recoveries in a storage stability study. In general, it 

appeared that parent fluazinam degraded moderately rapidly in studies conducted in Ephrata, 

Washington, Kempton, North Dakota, Porterville, California, and Monctezuma, Georgia. The 

dissipation half-lives ranged from 9 to 49 days. These half-lives are in agreement with the 

aerobic soil metabolism half-lives. At this time, the EFED has two newly submitted terrestrial 

field dissipation studies, which are in review.

Bioaccumulation 

Fluazinam demonstrated some potential to bioaccumulate in fish. The maximum BCF’s were 

348X for fillet, 1220 for whole fish, and 1850 for viscera, all of which were obtained with the 

phenyl label material. Fish residues identified included the parent compound, AMPA, MAPA 

and DAPA. Depuration was moderately slow. More than 67% of the residues were eliminated 

from the fillet during the 21-day depuration phase.

The fate and transport characterization also includes the various degradation and transformation

products formed by each process in the studies reviewed. Table 5 provides a summary of these 

transformation products.

Table 5. Summary of degradate formation from degradation of fluazinam.

STUDY TYPE

DEGRADATE and MAXIMUM CONCENTRATION

CAPA, G-504, HYPA AMPA, MAPA, DAPA, DCPA (% applied) SOURCE

Hydrolysis CAPA 34% at 28 days

pH 7; 84-85% at 20 days 

at pH 9

– – MRID: 42208412.

Aqueous Photolysis G-504 was 14.0-17.1% 

by 7-10 days

_ – MRID: 444807312, 

43521009, 45584204.

Soil Photolysis HYPA, detected > dark 

control

AMPA detected > dark 

control

– MRID: 44807313, 

45584204.

Aerobic Soil Metabolism HYPA, MAPA and DAPA detected (in the SL studies conducted at 1 kg/ha) MRID: 42208413, 

42208414.

Anaerobic Soil Metabolism HYPA was 11.0% at 60 

days for the SL flooded 

at 30 days

MAPA was 29.8% at 14 

days for the SL flooded 

at zero time

– MRID: 42208413, 

42208414.

Aerobic Aquatic Metabolism CAPA 12.6% at 72 hr DAPA: 19.0% by 240 hr DCPA: 11.3% at 24 hr MRID: 44807314.

Anaerobic Aquatic Metabolism AMPA 24.2% at 0.2 day DAPA: 32.7% at day 30 SDS-67200 39.6% by 

day 14

MRID: 43521010.

Terrestrial Field Dissipation MAPA, CAPA, and HYPA were monitored; however, there were problems 

with the storage stability data for the degradates.

MRID: 44807318, 

44807320, 44807316, 

44807319, 44807317.
13

 

4. Receptors

4.1. Aquatic and Terrestrial Effects

The receptor is the biological entity that is exposed to the stressor (EPA, 1998). Due to the 

outdoor uses of fluazinam, the types of receptors that may be exposed include both aquatic and 

terrestrial receptors, such as birds, reptiles, mammals and freshwater and estuarine/ marine fish, 

non-target invertebrates and terrestrial and aquatic plants. This list may not be comprehensive. 

Spray drift and runoff exposures are expected for both ground and aerial (potato only) 

applications of fluazinam. Consistent with the process described in the Overview Document 

(EPA, 2004), this risk assessment uses a surrogate species approach in its evaluation of 

fluazinam. Toxicological data generated from surrogate test species, which are intended to be 

representative of broad taxonomic groups, are used to extrapolate to potential effects on a variety

of species (receptors) included under these taxonomic groupings. 

Table 6 provides a summary of the taxonomic groups and the surrogate species tested to help 

understand potential ecological effects of pesticides to these non-target taxonomic groups. In 

addition, the table provides a preliminary overview of the potential acute toxicity of fluazinam

by providing the acute toxicity classifications.

Terrestrial Species

The available toxicity data suggests that fluazinam ranges from slightly toxic to practically

nontoxic for birds. An LD50=1782 mg/kg per body weight for quail (MRID 422486-23) is the 

most sensitive endpoint and will be used in the risk assessment. A quail LC50 >10500 mg/kg 

(MRID 422486-24) as well as a mallard LD50 > 4191 mg/kg (MRID 422486-22) and an LC50

>10,600 mg/l (MRID 422486-25) indicate that fluazinam is practically nontoxic to birds. A 

twenty-two week quail reproductive study resulted in a NOEL=200 mg/kg for 14-day survivor 

weight. A twenty-one week avian reproduction toxicity study (MRID 448319-07) shows that 

fluazinam exposure can result in growth reduction in young (14-day old survivors weight) with a 

NOAEL = 200 mg/kg and LOAEL = 500 mg/kg.

Mammalian toxicity data (MRID 422486-03) suggest that this compound is practically nontoxic 

to small mammals on an acute basis (rat LD50 = 4,300 mg/kg). Reproductive effects that were 

based on a decreased number of implantation sites and decreased litter size were noted at an 

LOAEC = 500 ppm (NOAEC = 100 mg/kg).

Terrestrial invertebrates are represented by the honey bee. Acute toxicity on honeybees show 

that fluazinam is practically nontoxic to bees based on an LD50 > 200 μg a.i./bee (MRID 422084-

11). A toxicity test for the formulated product was also provided. A 48-h LD50>4.0 μg/bee 

indicates this fluazinam product (49.7%) is practically non-toxic to bees.
14

Aquatic Species

The effect of fluazinam to freshwater fish is estimated for both cold and warm water fish. 

Fluazinam is considered to be very highly toxic to the freshwater rainbow trout (Oncorhynchus 

mykiss) on an acute basis, with an LC50 = 36 μg/l (33-56 μg/l) (MRID 429749-04). This rainbow 

trout estimate is the most sensitive value and will be used in the risk assessment. Another 

rainbow trout study (MRID 422084-09) resulted in an LC50=110 μg/l (100-130 μg/l). Another 

fish study for the bluegill resulted in an LC50 = 52.7 μg/l (47.1-59 μg/l), indicating fluazinam is 

very highly toxic to fish (MRID 429749-05). An invalid non-guideline toxicity study for the carp 

(Cyprinus carpio) was also submitted (MRID 422084-08). 

In addition to the acute fish studies, two chronic studies, an early life and a life-cycle study, were 

submitted. A chronic freshwater life cycle fish study resulted in a 278 day NOAEC=0.69 μg/l for 

a fathead minnow (MRID 448073-29) based on hatching success. A chronic study resulted in a 

NOAEC=5.3 μg/l and a LOEC-10 μg/l for a 30 day early life test (MRID 448073-27) with larval 

survival as the endpoint effected.

Daphnia are used as a surrogate for freshwater invertebrates for both acute and chronic effects. 

Acute toxicity values for aquatic invertebrates suggest that fluazinam is highly toxic to 

freshwater invertebrates (Daphnia EC50 = 180 μg/l (MRID 422084-10) to 222 μg/l (MRID 

429749-06). Chronic toxicity to invertebrates is only represented through the Daphnia magna

life cycle (MRID 448073-28) where the NOAEC was calculated at 68 μg/l and the LOAEC at 

0.140 μg/l. The endpoints affected for this study were reproductive and weight effects.

Estuarine/marine fish are represented by the sheepshead minnow (Cyprinodon variegatues) with

a toxicity study indicating fluazinam is highly toxic to estuarine/marine fish. An acute toxicity

study (MRID 448073-25) resulted in LC50 = 120 μg/l (80-240 μg/l). The chronic fish early lifestage study was classified as supplemental and resulted in a NOEL>26 μg/l (MRID458221-02).

This study does not satisfy the guideline requirement for a chronic estuarine/marine fish study.

Estuarine/marine aquatic invertebrates are represented by the oyster and mysid with toxicity

studies indicating fluazinam is very highly toxic to both. An acute toxicity study (MRID 448073-

24) resulted in an oyster (Crassostrea virginica) EC50 = 4.7 μg/l (3.6-6.0 μg/l). The acute study 

(MRID 448073-26) for the mysid shrimp (Americamysis bahia) resulted in an EC50 = 39 μg/l 

(34-45 μg/l). The results from the oyster study will be used in this assessment because it resulted 

in the most sensitive acute endpoint. A chronic mysid reproductive study (MRID 458221-01 was 

classified as supplemental based on missing raw data. The missing information has been 

requested from the conditional registration data call-in. 

Plants

An acceptable seedling emergence Tier I study (MRID 461728-01) using the dicots cabbage, 

carrot, cucumber, lettuce radish, soybean and tomato and the monocots corn, oat, onion and 

ryegrass was received. The toxicity test resulted in an EC25>0.78lbs a.i./A based on no observed

effects at the highest tested concentration. . 
15

Terrestrial

The effect of fluazinam on terrestrial plants is represented through the seedling emergence and 

vegetative vigor studies. An acceptable seedling emergence study (MRID 461728-01) resulted in

no effect at the highest tested concentration of 0.78 lb/A. A Tier I terrestrial seedling emergence 

study (MRID 448073-32 and 448073-33) resulted in a 14 day EC25<1.5 lb/A for tomato. No 

acceptable vegetative vigor studies have been submitted.

Aquatic Plants

The effect of fluazinam on aquatic plants is represented by vascular and nonvascular species. No 

acceptable vascular aquatic plant studies have been submitted, but a Lemna study was requested 

in the conditional registration. One acceptable nonvascular plant study was submitted. An 

acceptable blue-green algae (Anabaena flos-aquae) study (MRID 458221-06) resulted in an 

EC50=9200 μg/l. A supplemental study with the green algae Pseudokirchneriella subcapitata), a 

surrogate for nonvascular aquatic plants, was submitted and resulted in a 96 hour EC50=180 μg/l 

(160-200 μg/l) (MRID 448073-34). This study does not satisfy the nonvascular plant 

requirement. Several invalid nonvascular studies were submitted (MRIDs 445221-04, 458221-05 

and 458221-07). 

Table 6. Test Species Evaluated for Assessing Potential Ecological Effects of Fluazinam and the 

Associated Acute Toxicity Classification

Taxonomic Group Example(s) of Surrogate Species Acute Toxicity Classification

Birds1

Bobwhite (Colinus virginianus)

Quail 14d LD50=1782 mg/kg

(MRID 42248623)

Slightly toxic

Quail 8d LC50 > 10500 mg/kg 

body weight (MRID 422486-24) 

Practically non-toxic

Avian Reproduction

Bobwhite Quail 22 week

NOEL=200 mg/kg

(MRID 448073-23)

Mallard (Anas platyrhynchos)

Mallard 14d LD50>4191mg/kg 

(MRID 422486-22)

Practically nontoxic

Mallard LC50 > 10600 mg/kg 

Mallard NOEC = 651 mg/kg 

(MRID 422486-25)

Practically Non-toxic
16

Table 6. Test Species Evaluated for Assessing Potential Ecological Effects of Fluazinam and the 

Associated Acute Toxicity Classification

Taxonomic Group Example(s) of Surrogate Species Acute Toxicity Classification

Avian Reproduction

Mallard Duck 21 week 

LOEL=500 mg/L

(MRID 44831907)

Mammals Laboratory rat (Rattus norvegicus)

LD50 = 4300 mg/kg (MRID 

422486-03) Practically NonToxic

Insects Honey bee (Apis mellifera L.)

48 h LD50 >200 μg/bee for

(MRID 422084-11)

Practically nontoxic

48 h LD50>4.0 μg/bee for 

49.7%a.i. (MRID 422084-11)

Freshwater Fish2

BlueGill (Lepomis macrochirus)

Bluegill LC50=52.7 μg/L (47.1-

59 μg/L) 

(MRID 429749-05)

Very highly toxic 

Rainbow trout (Oncorhynchus mykiss)

Rainbow trout LC50=110 μg/L 

(100-130 μg/L) 

(MRID 422084-09)

Highly toxic

Rainbow trout LC50=36 μg/L 

(33-56μg/L)

(MRID 429749-04)

Very highly toxic

Carp (Cyprinus carpio)

Carp 96h LC50=145 μg/L (120-

222 μg/L)

(MRID 422084-08)

Highly toxic

Fathead minnow (Pimephales

promelas)

Early life 30d NOEC=5.3 μg/L

LOEC=10 μg/l

(MRID 448073-27)

Life cycle 278d

NOEC = 0.69 μg/L

LOEC=1.4 μg/l

(MRID448073-29)

Acceptable

Aquatic Invertebrates Daphnia magna

Acute Daphnia EC50=180 μg/L 

(140-222 μg/L)

(MRID 422084-10) 

Highly toxic
17

Table 6. Test Species Evaluated for Assessing Potential Ecological Effects of Fluazinam and the 

Associated Acute Toxicity Classification

Taxonomic Group Example(s) of Surrogate Species Acute Toxicity Classification

Acute Daphnia EC50=222 μg/l

(MRID 429749-06)

Highly toxic

Lifecycle Daphnia 

NOEC=68 μg/L

21d LOEC=140 μg/L

(MRID448073-28)

Estuarine/marine fish Sheepshead minnow (Cyprinodon 

variegatues)

96h LC50=120μg/l (80-240 

μg/l)(MRID 448073-25

Highly toxic 

Chronic: NOEC >26 μg/l all 

endpoints

(MRID 458221-02)

Supplemental (Not Repairable)

Estuarine/marine 

invertebrates

Mysid shrimp (Americamysis bahia)

Acute Mysid 96h LC50=39μg/l 

(34-45 μg/l)(MRID 448073-26

Very highly toxic 

Chronic NOEC= 2.0 μg/l 

reproductive success

(MRID 458221-01)

Supplemental (May be Upgraded)

Eastern oyster (Crassostrea virginica)

Acute oyster 96h LC50=4.7 μg/l

(3.6-6.0 μg/l)

(MRID 448073-24)

Very highly toxic

Terrestrial plants3

Monocots – corn (Zea mays)

Dicots – Tomato (Lycopersicon 

esculentum)

VVE: Tomato 14D 

EC25<1.5lb/A

(MRID 448073-32 and MRID 

448073-33)

Tier I SE: EC25> 0.78 lb/A

(MRID 461728-01)

Acceptable

Monocots – corn (Zea mays)

Dicots – Tomato (Lycopersicon 

esculentum)

Tier I Vegetative Vigor

(MRID 461728-02)

Invalid

Aquatic plants and algae

Duckweed (Lemna gibba) Lemna –Required

(MRID 458221-03)

invalid

Green algae (Pseudokirchneriella 

subcapitata)

Algae 96h EC50=180μg/l

(160-200 μg/l)

(MRID 448073-34)

Supplemental

(MRID 445221-04)

Invalid

Blue green Algae (Anabaena flosaquae)

96 h EC50=9200μg/l

(MRID 458221-06

Acceptable
18

Table 6. Test Species Evaluated for Assessing Potential Ecological Effects of Fluazinam and the 

Associated Acute Toxicity Classification

Taxonomic Group Example(s) of Surrogate Species Acute Toxicity Classification

Freshwater Diatom (Navicula 

pelliculosa)

(MRID 458-221-05)

Invalid

Marine Diatom (Skeletonema costatum)

(MRID 458221-07)

Invalid 

1 Birds represent surrogates for terrestrial-phase amphibians and reptiles.-

2

Freshwater fish may be surrogates for aquatic-phase amphibians.

3

Four species of two families of monocots, of which one is corn; six species of at least four dicot families, of which one is 

soybeans.

4.2. Incident Database Review

Incident Reports: There are no aquatic or terrestrial ecological incident reports for fluazinam in 

the Agency’s Ecological Incident Information System (EIIS). No incidents of contamination of 

surface, ground and drinking water have been reported to the Agency. A lack of reported 

incidents does not necessarily mean that such incidents have not occurred. In addition, incident 

reports for non-target plants and animals typically provide information on mortality events only. 

Reports for other adverse effects, such as reduced growth or impaired reproduction, are rarely

received.

4.3. Ecosystems Potentially at Risk 

Fluazinam may be applied on a variety of food crops, including beans leafy vegetables, 

bushberries, ginseng, peanuts and potatoes. Thus, the ecosystems at risk may be extensive in 

scope, and as a result it may not be possible to identify specific ecosystems during the 

development of a baseline risk assessment. In general terms, terrestrial ecosystems potentially at 

risk due to the use of fluazinam, could include the treated field and areas immediately adjacent to 

the treated field that may receive drift or runoff. Areas adjacent to the treated field could include 

cultivated fields, fencerows and hedgerows, meadows, fallow fields or grasslands, woodlands, 

riparian habitats and other uncultivated areas. Due to the persistence of the total residues of 

fluazinam (that is, total residues of parent and its transformation products), they are expected to 

drift and/ or runoff due to application to food crops, resulting in possible exposure to aquatic 

ecosystems. Aquatic ecosystems potentially at risk due to the use of fluazinam include water 

bodies adjacent to, or down stream from, the treated field and might include impounded bodies 

such as ponds, lakes and reservoirs, or flowing waterways such as streams or rivers. For uses in 

coastal areas, aquatic habitat also includes marine ecosystems, including estuaries. 

5. Assessment Endpoints

Assessment endpoints are defined as “explicit expressions of the actual environmental value that 

is to be protected.” Defining an assessment endpoint involves two steps: 1) identifying the 

valued attributes of the environment that are considered to be at risk; and 2) operationally
19

defining the assessment endpoint in terms of an ecological entity (i.e., a community of fish and 

aquatic invertebrates) and its attributes (i.e., survival and reproduction). Therefore, selection of 

the assessment endpoints is based on valued entities (i.e., ecological receptors), the ecosystems 

potentially at risk, the migration pathways of pesticides, and the routes by which ecological 

receptors are exposed to pesticide-related contamination. The selection of clearly defined 

assessment endpoints is important because they provide direction and boundaries in the risk 

assessment for addressing risk management issues of concern. Changes to assessment endpoints 

are typically estimated from the available toxicity studies, which are used as the measures of 

effects to characterize potential ecological risks associated with exposure to pesticides, such as 

fluazinam.

To estimate exposure concentrations, the ecological risk assessment considers a single 

application at the maximum application rate to fields that have vulnerable soils. The most 

sensitive toxicity endpoints are used from surrogate test species to estimate treatment-related 

direct effects on acute mortality and chronic reproductive, growth and survival assessment 

endpoints. Toxicity tests are intended to determine effects of pesticide exposure on birds, 

mammals, fish, terrestrial and aquatic invertebrates, and plants. These tests include short-term 

acute, sub-acute, and reproduction studies and are typically arranged in a hierarchical or tiered 

system that progresses from basic laboratory tests to applied field studies. The toxicity studies 

are used to evaluate the potential of a pesticide to cause adverse effects, to determine whether 

further testing is required, and to determine the need for precautionary label statements to 

minimize the potential adverse effects to non-target animals and plants.

6. Conceptual Model

For a pesticide to pose an ecological risk, it must reach ecological receptors in biologically

significant concentrations. An exposure pathway is the means by which a pesticide moves in the 

environment from a source to an ecological receptor. For an ecological pathway to be complete, 

it must have a source, a release mechanism, an environmental transport medium, a point of 

exposure for ecological receptors, and a feasible route of exposure.

A conceptual model provides a written description and visual representation of the predicted 

relationships between fluazinam, potential routes of exposure, and the predicted effects for the 

assessment endpoint. A conceptual model consists of two major components: risk hypothesis and 

a conceptual diagram (EPA, 1998).

6.1. Risk Hypothesis

Risk hypotheses are specific assumptions about potential adverse effects (i.e., changes in 

assessment endpoints) and may be based on theory and logic, empirical data, mathematical 

models, or probability models (EPA 1998). For this assessment, the risk is stressor-initiated, 

where the stressor is the release of fluazinam into the environment. The following risk 

hypothesis is presumed for this screening-level assessment:
20

The use of fluazinam will likely involve situations where terrestrial and aquatic animals 

and plants will be exposed to the chemical and/or its transformation products. Based on 

information on environmental fate, mode of action, direct toxicity and potential indirect 

effects, EFED assumes potential, for fluazinam and its transformation products, to cause 

reduced survival, growth, and reproduction to terrestrial and/or aquatic animals and 

plants as a result of the proposed use of the pesticide.

The conceptual model is a generic graphic depiction of the risk hypothesis. It includes the 

potential pesticide or stressor, fluazinam (and its transformation products), the source of the 

pesticide and/or transport pathways, exposure media, exposure point, biological receptor types, 

and attribute changes.

6.2. Conceptual Diagram

The conceptual site model is a generic graphic depiction of the risk hypothesis, and assumes that 

the fungicide fluazinam (and its transformation products), having outdoor uses, is capable of 

affecting aquatic and terrestrial animals provided that environmental concentrations are 

sufficiently elevated as a result of proposed label uses. Based on an examination of the 

physicochemical properties of fluazinam, the fate and disposition in the environment, and mode 

of application, a conceptual model was developed that represents the possible relationships 

between the stressors, ecological receptors, and the assessment endpoints. Through a 

preliminary iterative process of examining available data, the conceptual model (i.e., the 

representation of the risk hypothesis) may be refined to reflect the likely exposure pathways and 

the organisms that are most relevant and applicable to this assessment (see Figure 2, below). It 

includes the potential pesticide or stressor (fluazinam and its transformation products), the 

sources and/ or transport pathways, exposure media, exposure points, biological receptor types 

and attribute changes.

In order for a chemical to pose an ecological risk, it must reach ecological receptors in 

biologically significant concentrations. An exposure pathway is the means by which a pesticide 

moves in the environment from a source to an ecological receptor. For an ecological exposure 

pathway to be complete, it must have a source, a release mechanism, an environmental transport 

medium, a point of exposure for ecological receptors, and a feasible route of exposure. In 

addition, the potential mechanisms of degradation/ transformation (i.e., which degradation/

transformation products may form in the environment, in which media, and how much) must be 

understood, especially for a chemical whose metabolites/ transformation products are of greater 

toxicological concern than the parent compound. The assessment of ecological exposure 

pathways, therefore, includes an examination of the source and potential migration pathways for 

constituents, and the determination of potential exposure routes.

Under the possible uses of fluazinam, the sources and mechanisms of release of the compound 

are from ground or aerial (only for potatoes) spray applications. Surface runoff from the areas of 

application is assumed to depend on factors such as topography, irrigation, and rainfall events. 

Direct deposition may result in contamination of food items that may be consumed by terrestrial 

organisms. Spray drift results in contaminated adjacent areas, such as bodies of water.
21

For aquatic receptors, the major point of exposure is through direct contact with the water 

column, sediment, and pore water (gill/ integument) contaminated with spray drift (from spray

application) and/ or runoff from treated areas. Indirect effects to aquatic organisms (especially 

fish) can also occur through impact to various food chains. The representative aquatic receptors 

are certain freshwater and estuarine/ marine fish, invertebrates, and, in certain cases, aquatic 

plants. The major point of exposure for terrestrial animals is consumption of food contaminated 

with residues such as grass, foliage, and small insects. For plants, the point of exposure is root 

uptake. The representative terrestrial receptors are mammals, birds, and, in certain cases, 

terrestrial plants. The attribute changes used to assess risk terrestrial receptors depend on the 

type of test (e.g., reduced survival, growth, or reproduction for animals and seedling emergence 

and vegetative vigor for plants). It should be noted, that these species do not cover all the 

possible species in the animal and plant kingdoms; certain taxa are considered as surrogates for 

other taxa. For example, fish are considered surrogates for aquatic phase amphibians.

 

7. Analysis Plan 

In order to address the risk hypothesis, the potential for adverse effects on the environment is 

estimated. Usage, environmental fate and transport, and ecological effects of fluazinam are 

characterized and integrated to assess the risks. This is accomplished using a risk quotient (ratio 
22

of exposure concentration to effects concentration) approach. Although risk is often defined as 

the likelihood and magnitude of adverse ecological effects, the risk quotient-based approach does 

not provide a quantitative estimate of likelihood and/or magnitude of an adverse effect. 

However, as outlined in the Overview Document (USEPA 2004), the likelihood of effects to 

individual organisms from particular uses of a chemical is estimated using the probit doseresponse slope and either the level of concern (discussed below) or the actual calculated risk 

quotient value. 

This analysis plan will be revisited and may be revised depending upon the data available in the 

open literature and the information submitted by the public in response to the opening of the 

Registration Review docket.

7.1. Stressors of Concern

The focus of this assessment is on the fluazinam, parent material. However, the Agency will 

review open literature to identify degradate(s) of potential toxicological concern. Various 

degradates of fluazinam, such as HYPA, are structurally related to the parent compound, and 

persist more than fluazinam.

Toxicity data for environmental mixtures of fluazinam with other pesticides (those mixtures 

occurring in the environment following application), if available, may be presented as part of the 

ecological risk assessment. It is expected that the toxic effect of fluazinam, in combination with 

other pesticides used in the environment, is likely to be a function of many factors including but 

not necessarily limited to: (1) the exposed species, (2) the co-contaminants in the mixture, (3) the 

ratio of fluazinam and co-contaminant concentrations, (4) differences in the pattern and duration 

of exposure among contaminants, and (5) the differential effects of other physical/ chemical 

characteristics of the receiving waters (e.g. organic matter present in sediment and suspended 

water). Quantitatively predicting the combined effects of all these variables on mixture toxicity

to any given taxa with confidence is beyond the capabilities of the available data and 

methodologies. However, a qualitative discussion of implications of the available pesticide 

mixture effects data on the confidence of risk assessment conclusions will be addressed as part of 

the uncertainty analysis.

7.2. Measures of Exposure

In order to estimate risks of fluazinam exposures in aquatic and terrestrial environments, all 

exposure modeling and resulting risk conclusions will be made based on maximum application 

rates for the current use patterns. Measures of exposure are based on aquatic and terrestrial 

models that predict estimated environmental concentrations of fluazinam (plus its transformation 

products) using maximum labeled application rates and methods, as well as any mitigation 

measures specifically indicated on the label. The models used to predict aquatic EECs are the 

Pesticide Root Zone Model coupled with the Exposure Analysis Model System 

(PRZM/EXAMS). The model used to predict terrestrial exposure is T-REX. The model used to 

derive EECs relevant to terrestrial and wetland plants is TerrPlant. These models are 
23

parameterized using relevant reviewed registrant-submitted environmental fate and transport 

data.

PRZM (v3.12.2, May 2005) and EXAMS (v2.98.4.6, April 2005) are screening simulation 

models coupled with the input shell PE5.pl (August, 2007) to generate daily exposures and 1-in10 year EECs of fluazinam plus its transformation products, that may occur from spray drift and 

runoff to surface water bodies adjacent to application sites. PRZM simulates pesticide 

application, movement and transformation on an agricultural field and the resultant pesticide 

loadings to a receiving water body via runoff, erosion and spray drift. The EXAMS model 

simulates the fate of the pesticide and resulting concentrations in the water body. The standard 

scenario used for ecological pesticide assessments assumes application to a 10-hectare 

agricultural field that drains into an adjacent 1-hectare water body that is 2 meters deep (20,000 

m

3

volume) with no outlet. PRZM/EXAMS is used to estimate screening-level exposure of 

aquatic organisms to fluazinam plus its transformation products. The measure of exposure for 

aquatic species is the 1-in-10 year return peak or rolling mean concentration. The 1-in-10 year 

peak is used for estimating acute exposures of direct effects to aquatic organisms. The 1-in-10-

year 60-day mean is used for assessing chronic exposure to fish and aquatic-phase amphibians. 

The 1-in-10-year 21-day mean is used for assessing aquatic invertebrate chronic exposure.

Exposure estimates for terrestrial animals assumed to be in the target area are derived using the 

T-REX model (version 1.3.1, 12/07/2006). For granular pesticides (not applicable for 

fluazinam), this includes the amount of pesticide per square foot, used in LD50 per square foot 

risk assessment calculations. EECs for terrestrial plants inhabiting dry and wetland areas are 

derived using TerrPlant (version 1.2.2, 12/26/2006). This model uses estimates of pesticides in 

runoff and in spray drift (assumed to be 0% for granulars) to calculate EECs. EECs are based 

upon solubility, application rate and minimum incorporation depth.

 

7.3. Measures of Effect

Ecological effects data are used as measures of direct and indirect effects to biological receptors. 

Data are typically obtained from registrant-submitted studies or from literature studies identified 

by ECOTOX. The ECOTOX database provides more ecological effects data in an attempt to 

bridge existing data gaps. ECOTOX is a source for locating single chemical toxicity data and 

potential chemical mixture toxicity data for aquatic life, terrestrial plants, and wildlife.

ECOTOX was created and is maintained by the USEPA, Office of Research and Development, 

and the National Health and Environmental Effects Research Laboratory's Mid-Continent 

Ecology Division.

Where available, sub-lethal effects observed in both registrant-submitted and open literature 

studies will be evaluated qualitatively. Such effects may include behavioral changes (e.g., 

lethargy and changes in coloration). Quantitative assessments of risks, though, are limited to 

those endpoints that can be directly linked to the Agency’s assessment endpoints of impaired 

survival, growth and reproduction.
24

The assessment of risk for direct effects to non-target organisms makes the assumption that the 

toxicity of fluazinam to birds is similar to terrestrial-phase amphibians and reptiles. The same 

assumption is made for fish and aquatic-phase amphibians. 

The acute measures of effect used for animals in this assessment are the LD50, LC50 and EC50. 

LD stands for "Lethal Dose", and LD50 is the amount of a material, given all at once, that is 

estimated to cause the death of 50% of the test organisms. LC stands for “Lethal Concentration” 

and LC50 is the concentration of a chemical that is estimated to kill 50% of the test organisms. 

EC stands for “Effective Concentration” and the EC50 is the concentration of a chemical that is 

estimated to produce a specific effect in 50% of the test organisms. Endpoints for chronic 

measures of exposure for listed and non-listed animals are the NOAEL/NOAEC and NOEC. 

NOAEL stands for “No Observed-Adverse-Effect-Level” and refers to the highest tested dose of 

a substance that has been reported to have no harmful (adverse) effects on test organisms. The 

NOAEC (i.e., “No-Observed-Adverse-Effect-Concentration”) is the highest test concentration at 

which none of the observed effects were statistically different from the control. The NOEC is 

the No-Observed-Effects-Concentration. For non-listed plants, only acute exposures are 

assessed (i.e., EC25 for terrestrial plants and EC50 for aquatic plants); for listed plants either the 

NOAEC or EC05 is used.

 

7.4. Integration of Exposure and Effects

Risk characterization is the integration of exposure and ecological effects characterization to 

determine the potential ecological risk from the use of pesticides and the likelihood of direct and 

indirect effects to non-target organisms in aquatic and terrestrial habitats. The exposure and 

toxicity effects data are integrated in order to evaluate the risks of adverse ecological effects on 

non-target species. For the assessment of risks, the risk quotient (RQ) method is used to 

compare exposure and measured toxicity values. EECs are divided by acute and chronic toxicity

values. The resulting RQs are then compared to the Agency’s Levels of Concern (LOCs) 

(USEPA 2004). These criteria will be used to indicate when fluazinam’s uses, as directed on the 

label, have the potential to cause adverse direct or indirect effects to non-target organisms. In 

addition, incident data from the EIIS will be considered as part of the risk characterization.

 

7.5. Deterministic and Probabilistic Assessment Methods

The quantitative assessment of risk will primarily depend on the deterministic point-estimate 

based approach described in the risk assessment. An effort may also be made to further 

qualitatively describe risk using probabilistic tools that the Agency has developed. These tools 

have been reviewed by FIFRA Scientific Advisory Panels (http://www.epa.gov/scipoly/sap/index.htm)

and have been deemed as appropriate means of refining assessments where deterministic 

approaches have identified risks.
25

7.6. Endangered Species Assessments

Consistent with the Agency’s responsibility under the Endangered Species Act (ESA), the 

Agency will evaluate risks to Federally-listed threatened and/or endangered (listed) species from 

registered uses of fluazinam. This assessment will be conducted in accordance with the 

Overview Document (USEPA 2004), provisions of the ESA, and the Services’ Endangered 

Species Consultation Handbook (USFWS/NMFS, 1998).

The assessment of effects associated with the registration of fluazinam is based on an action area. 

The action area is considered to be the area directly or indirectly affected by the federal action, as 

indicated by the exceedance of Agency Levels of Concern (LOCs) used to evaluate direct or 

indirect effects. The Agency’s approach to defining the action area under the provisions of the 

Overview Document (USEPA 2004) considers the results of the risk assessment process to 

establish boundaries for that action area with the understanding that exposures below the 

Agency’s defined LOCs constitute a no-effect threshold. For the purposes of this assessment, 

attention will be focused on the footprint of the action (i.e., the area where fluazinam application 

occurs), plus all areas where offsite transport may result in potential exposure that exceeds the 

Agency’s LOCs. Specific measures of ecological effect that define the action area for listed 

species include any direct and indirect effects and/ or potential modification of its critical habitat, 

including reduction in survival, growth, and reproduction as well as the full suite of sub-lethal 

effects available in the effects literature. Therefore, the action area extends to a point where 

environmental exposures are below any measured lethal or sub-lethal effect threshold for any 

biological entity at the whole organism, organ, tissue, and/ or cellular level of organization. In 

situations where it is not possible to determine the threshold for an observed effect, the action 

area is not spatially limited and is assumed to be the entire United States.

7.7. Drinking Water Assessment

A drinking water assessment will be conducted to support future human health risk assessments 

of fluazinam. The drinking water assessment will incorporate model estimates of fluazinam 

(fluazinam total residues of concern) in surface and ground waters. Concentrations in surface 

waters will be estimated using FQPA Index Reservoir Screening Tool (FIRST, v.1.1.1, 12/18/07) 

(or subsequently using PRZM/ EXAMS - see description above, if refinements are required). 

Ground water estimates of concentrations will be made using the Screening Concentration in 

Ground Water (SCI-GROW) model (v.2.3, July 2003). The drinking water assessment will also 

include a summary of available surface and ground water monitoring data.

7.8. Preliminary Identification of Data Gaps

7.8.1. Fate

The environmental fate database is substantially complete.
26

835.6100: Terrestrial Field Dissipation. EFED believes that the available Terrestrial Field 

Dissipation studies provide useful supplemental information about the parent fluazinam. 

However, poor recoveries for two of the transformation products upon storage stability cast 

doubts over the results obtained for them in the field. The registrant submitted two new 

terrestrial field dissipation studies (MRID#s 45584207 and 45584208). These studies are 

currently in review.

835.6100, 835.6200: Environmental Chemistry Methods (ECMs) and Independent 

Laboratory Validations (ILVs) for Soil, Water and Sediment. ECMs associated with the 

Terrestrial Field Dissipation study (Field dissipation §158.1300; OPPTS guidelines 835.6100, 

835.6200, and 835.6300), along with successful confirmatory method trials (validation) by an 

independent laboratory (i.e. ILVs), are required. If there is risk concern for a given taxon, ECMs 

should be available for the environmental media in which organisms of the taxon reside. These 

ECMs should have limits of quantitation for the residues of concern that are lower than the 

relevant toxicological levels of concern. The latter risk assessments conducted on fluazinam 

indicated risk concerns for organisms living in freshwater and estuarine/ marine bodies of water. 

In addition, there were risk concerns for estuarine/ marine organisms living in the benthos. 

Therefore, ECMs for water and sediment are required in addition to the ECM for soil. The 

ECMs should include parent and those residues found in the laboratory studies that exceeded 

10% of the applied. The following appear to be the residues of concern for each media:

 Soil – parent and HYPA

 Water – parent, DCPA, HYPA, CAPA, DAPA and AMPA

 Sediment – parent, DAPA and AMPA

The registrant is encouraged to submit state-of-the-art environmental chemistry methods; further, 

multi-residue methods (MRMs) for soil, water and sediment are preferred.

Table 7 lists the status of the environmental fate data requirements.

Table 7. Summary of Environmental Fate Data Requirements for Fluazinam

Study Identification

Use 

Pattern1

Does EPA Have 

Data To Satisfy 

This 

Requirement? Bibliographic Citation

Must Additional Data 

Be Submitted Under 

FIFRA 3(c)(2)(B)?

§158.1300 ENVIRONMENTAL FATE

Degradation Studies-Lab:

835.2120 Hydrolysis 1,2 Yes 42208412 No

835.2240 Photodegradation In 

Water

1,2 Yes 44807312, 43521009, 

45584204

No

835.2410 Photodegradation On 

Soil

1,2 Yes 42208413, 44807313, 

45584204

No

Metabolism Studies-Lab:

835.4100 Aerobic Soil 1,2 Yes 42208413, 42208414 No
27

Table 7. Summary of Environmental Fate Data Requirements for Fluazinam

Study Identification

Use 

Pattern1

Does EPA Have 

Data To Satisfy 

This 

Requirement? Bibliographic Citation

Must Additional Data 

Be Submitted Under 

FIFRA 3(c)(2)(B)?

835.4200 Anaerobic Soil 1,2 No 42208413, 42208414 No

835.4400 Anaerobic Aquatic 1,2 Yes 43521010 No

835.4300 Aerobic Aquatic 1,2 Yes 44807314 No

Mobility Studies:

835.1230 & 835.1240 Leaching -

Adsorption/ Desorption

1,2 Yes 44807314 No

835.1410 Volatility (Lab) 1,2 No NA No

Dissipation Studies-Field:

835.6100 Soil 1,2 Yes 44807318, 44807320, 

44807316, 44807319, 

44807317, 45584207, 

45584208

In reserve 

835.6100 Environmental Chemistry 

Methods (ECM) and Independent 

Laboratory Validation (ILV) – Soil, 

Water and Sediment

1,2 No N/A Yes

Ground Water Monitoring Studies:

835.7100 Ground Water 

Monitoring

1,2 No NA Reserved

§158.630 AQUATIC ORGANISMS TESTING

850.1730 Bioaccumulation in Fish 1,2 Yes 43521012 No

§158.1100 SPRAY DRIFT

201-1 Droplet Size Spectrum 1,2 No NA No2

202-1 Drift Field Evaluation 1,2 No NA No2

1. Use Patterns:1=Terrestrial/Food; 2=Terrestrial/Feed. 2. Data requirement covered by submission of the Spray Drift Task Force.

7.8.2 Effects

Table 8 lists required ecological studies for fluazinam. Based on new data requirements, a 

passerine acute oral toxicity test is required. Chronic estuarine/marine fish and aquatic 

invertebrate studies are requested based on potential exposure to estuarine/marine water bodies

and potential risk estimated in previous assessments. Studies will provide information to reduce 

uncertainty for nontarget and endangered species assessments. A whole sediment chronic
28

toxicity invertebrate study (850-1790) is requested to reduce the uncertainty of risk for chronic 

benthic organisms. 

Some of the submitted plant studies were deemed invalid and should be repeated. The following 

plant studies are needed:

123-1: Tier II - Terrestrial Plant Growth - Vegetative vigor. 

123-2: Tier II - Aquatic Plant Growth - duckweed (Lemna gibba), green algae 

(Pseudokirchneriella subcapitata), a freshwater diatom (Navicula) and a marine diatom 

(Skeletonema costatum). 

Table 8. Ecological Effects Data Requirements for Fluazinam

Data Requirement

Use

Pattern1

Does EPA Have

Data To Satisfy

This 

Requirement?

(Yes, No, or 

Partially)

Bibliographic

Citation

Must 

Additional

Data Be 

Submitted

Under FIFRA 

3(c)(2)(B)?

§158.490 WILDLIFE AND AQUATIC ORGANISMS

71-1(a) Acute Avian Oral, Quail or Duck 1,2 Yes 42248623, 42248622 No

71-1(a) Acute Avian Oral, Passerine 1,2 No Yes

71-2(a) Acute Avian Diet, Quail 1,2 Yes 42248624 No

71-2(b) Acute Avian Diet, Duck 1,2 Yes 42248625 No

71-3 Wild Mammal Toxicity 1,2 NA

71-4(a) Avian Reproduction Quail 1,2 Yes 448073-23 No

71-4(b) Avian Reproduction Duck 1,2 Yes 44831907 No

71-5(a) Simulated Terrestrial Field Study 1,2 NA

71-5(b) Actual Terrestrial Field Study 1,2 NA

72-1(a) Acute Fish Toxicity Bluegill 1,2 Yes 42974905 No

72-1(b) Acute Fish Toxicity (TEP) 1,2 NA

72-1(c) Acute Fish Toxicity Rainbow 

Trout 

1,2 Yes 42974904, 42208409 No

72-1(d) Acute Fish Toxicity Rainbow 

Trout (TEP)

1,2 NA

72-2(a) Acute Aquatic Invertebrate 1,2 Yes 42974906, 42208410 No

72-2(b) Acute Aquatic Invertebrate (TEP) 1,2 NA
29

Table 8. Ecological Effects Data Requirements for Fluazinam

Data Requirement

Use

Pattern1

Does EPA Have

Data To Satisfy

This 

Requirement?

(Yes, No, or 

Partially)

Bibliographic

Citation

Must 

Additional

Data Be 

Submitted

Under FIFRA 

3(c)(2)(B)?

72-3(a) Acute Est/Mar Toxicity Fish 1,2 Yes

Yes

44807325

45822102

No

No

72-3(b) Acute Est/Mar Toxicity Mollusk 1,2 Yes 44807324 No

72-3(c) Acute Est/Mar Toxicity Shrimp 1,2 Yes 44807326 No

72-3(d) Acute Est/Mar Toxicity Fish (TEP) 1,2 NA

72-3(e) Acute Est/Mar Toxicity Mollusk 

(TEP) 

1,2 NA

72-3(f) Acute Est/Mar Toxicity Shrimp 

(TEP) 

1,2 NA

72-4(a) Early Life Stage Fish 1,2 Yes (FW) 44807327 No

No

(Estuarine/marine)

458221-02 Yes2

72-4(b) Life Cycle Aquatic Invertebrate 1,2 Yes (FW) 448073-28 No

No

(Estuarine/marine)

458221-01 Yes2

72-5 Life Cycle Fish 1,2 Yes 448073-29 No

72-6 Aquatic Organism Accumulation 1,2 NA

72-7(1) Simulated Aquatic Field Study 1,2 NA

72-7(b) Actual Aquatic Field Study 1,2 NA

850-1790 Whole Sediment Chronic Toxicity 

Invertebrates

1,2 No Yes

§158.540 PLANT PROTECTION

122-1(a) Seed Germ, Seedling Emergence 1,2 Yes 461728-01 No

122-2 Aquatic Plant Growth 1,2 No Yes
30

Table 8. Ecological Effects Data Requirements for Fluazinam

Data Requirement

Use

Pattern1

Does EPA Have

Data To Satisfy

This 

Requirement?

(Yes, No, or 

Partially)

Bibliographic

Citation

Must 

Additional

Data Be 

Submitted

Under FIFRA 

3(c)(2)(B)?

122-1(b) Vegetative Vigor 1,2 No 461728-02

448073-32

448073-33

Yes2

123-2 Aquatic Plant Growth 1,2 No

No

No

No

Yes

No

448073-34

458221-03

458221-04

458221-05

458221-06

458221-07

Yes3

Yes3

Yes3

Yes3

No

Yes3

124-1 Terrestrial Field Study 1,2 NA

124-2 Aquatic Field Study 1,2 NA

§158.490 NONTARGET INSECT TESTING

141-1 Honey Bee Acute Contact 1,2 Yes 422084-11 No

141-2 Honey Bee Residue on Foliage 1,2 NA

141-5 Field Test for Pollinators 1,2 NA

1. Use Patterns:1=Terrestrial/Food; 2=Terrestrial/Feed

2. Guideline study is recommended based on review of unacceptable study submission.

3. Guideline study recommended based on review of invalid nonvascular study submission.
31

8. References

U.S. Environmental Protection Agency. 1998. Guidelines for Ecological Risk Assessment. 

Risk Assessment Forum, Office of Research and Development, Washington, D.C. EPA/630/R95/002F. April 1998. 

U.S. Environmental Protection Agency. 2000. Risk Characterization Handbook. Science Policy

Council, U.S. Environmental Protection Agency, Washington, D.C. 20460. EPA 100-B-00-002. 

December 2000.

U.S. Environmental Protection Agency. 2004. Overview of the Ecological Risk Assessment 

Process in the Office of Pesticide Programs, U.S. Environmental Protection Agency. 

Endangered and Threatened Species Effects Determinations. Office of Prevention, Pesticides 

and Toxic Substances, Office of Pesticide Programs, Washington, D.C. January 23, 2004.

U.S. Environmental Protection Agency. 2005. Generic Format and Guidance for the Level I 

Screening Ecological Risk Assessments Conducted in the Environmental Fate and Effects 

Division. Office of Pesticide Programs, Washington, D.C. January 24, 2005.

U.S. Fish and Wildlife Service (USFWS) and National Marine Fisheries Service (NMFS). 1998. 

Endangered Species Consultation Handbook: Procedures for Conducting Consultation and 

Conference Activities Under Section 7 of the Endangered Species Act. Final Draft. March 

1998.
32

Appendix A. SRRD data request justification tables

The following proposed Data Call-in tables include rationales for requiring the data requested in 

this problem formulation, explanations of the utility of the data, and explanations for how the 

data might impact risk assessment, following the format provided by SRRD.

Guideline Number: 835.6100

Study Title: Environmental Chemistry Methods (ECM) and Independent Laboratory Validation 

(ILV) for Soil, Water and Sediment

Rationale for Requiring the Data

According to the data requirements in 40 CFR Part 158, ECMs are currently required along with 

successful confirmatory method trials (validation) by an independent laboratory (i.e. ILVs). In addition 

to the method for soil, at this time, methods are required for water and sediment. Acceptable ECMs for 

the residues of concern (parent and its transformation products) should have levels of quantitation that 

are adequate to address risk concerns or that are at levels below the toxicological endpoints for the 

relevant aquatic organisms. The results of previous assessments indicate that there is risk for freshwater 

fish, and estuarine/ marine invertebrates and benthic organisms. Therefore, ECMs for water and 

sediment are required in addition to the ECM for soil. The ECMs should include parent and those 

residues found in the laboratory studies that exceeded 10% of the applied. The registrant is encouraged 

to submit state-of-the-art environmental chemistry methods; further, multi-residue methods (MRMs) for 

soil, water and sediment are preferred.

Practical Utility of the Data

How did the Agency make its registration decision without these data?

Instead of monitoring data, models were utilized to calculate the exposure (i.e. Estimated Environmental 

Concentrations, EECs), using available environmental fate data. Four terrestrial field dissipation studies 

were conducted with methods for parent and several of the transformation products for which there is no 

ECM or ILV.

How will the data be used? 

The data will be used to verify the suitability of the methods. Subsequently the methods could be used 

by states or other enforcement agencies, departments or entities, to monitor concentrations of the 

residues of concern. Validated analytical methods in environmental media (a.k.a., ECMs) are useful for 

conducting and evaluating submitted environmental fate and toxicity field and monitoring studies and 

for addressing potential risks to the environment posed by the use and/or accidental release of pesticides.

How could the data impact the Agency’s future decision-making?

If monitoring of the chemical is required or performed, the Agency could be able to determine if the 

chemical is present in the environment at concentrations that are threatening to wildlife (or to humans, in 

the case of drinking waters), according to the levels of concern (LOCs). If that is the case, measures to 

prevent these concentrations to occur could be taken. The data could also be used by enforcement 

entities like the states or government agencies or departments. Without these data, the potential for the 

determination of residues of fluazinam in soil, water and sediment is restricted. The lack of these data 

will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered 

Species Act, and could result in use restrictions for fluazinam which may otherwise be avoided, or which 

are unnecessarily severe.
33

Guideline Number: 850-2100

Study Title: Passerine Acute Avian Oral 

Rationale for Requiring the Data

Although an acute avian oral study was received the Agency updated its data requirements in 40 CFR 

Part 158 (October 26, 2007) to include an acute oral toxicity study for both a passerine species and either 

a waterfowl or an upland game species. Prior to starting toxicity testing, a protocol will need to be 

provided for review.

o Many passerine species utilize agricultural fields, forests, residential areas and 

surrounding areas, and, therefore, have the potential to be exposed to pesticides 

used in agricultural, forest, and residential settings

 It is likely that, for most pesticide use patterns, passerines are more likely 

to be exposed to pesticides than upland game species and waterfowl 

o Passerines are smaller and have faster metabolisms than the waterfowl and 

upland game bird species traditionally used in avian toxicity tests which could 

impact their sensitivity to chemicals

Practical Utility of the Data

How did the Agency make its registration decision without these data?

Since this is a new requirement, EPA was using the results from the toxicity tests for the waterfowl and 

the upland game bird.

How will the data be used? 

Data from passerine toxicity studies will be used to estimate potential risks to birds associated with uses 

of fluazinam. The data will reduce uncertainties associated with the current risk assessment for 

passerine species and will improve our understanding of the potential effects of fluazinam.

How could the data impact the Agency’s future decision-making?

Because birds significantly contribute to overall environmental quality, a solid understanding of the 

potential risks to birds, including passerine species,is essential for sound environmental management. 

Without acceptable data for fluazinam, the Agency cannot determine the levels of fluazinam that result 

in effects to passerine species. If the data indicates that registered fluazinam usage may pose a risk of 

adverse effects to non-target birds above the Agency Level of Concern, the Agency may explore 

decision options to mitigate this risk. The lack of these data will limit the flexibility the Agency and 

registrants have in coming into compliance with the Endangered Species Act, and could result in use 

restrictions for fluazinam which may otherwise be avoided, or which are unnecessarily severe.
34

Guideline Number: 850.1450

Study Title: Fish Early Life-Stage (saltwater) Study

Rationale for Requiring the Data

A chronic study submitted for estuarine/marine fish in response to the RED was classified as 

supplemental based on number of replicates and no observable response at the highest concentration 

tested. A new study is required based on the absence of acceptable data to satisfy the guideline for an 

early life stage estuarine/marine fish study. 

Chronic studies on estuarine/marine organisms are required to support uses by which significant 

concentrations of a chemical are expected to enter into estuarine/marine environments. Persistence in 

water (e.g., half-life in water >4 days) can also trigger this data requirement. 

Practical Utility of the Data

How did the Agency make its re-registration decision without these data?

The previous assessment provided for a conditional registration while waiting for acceptable data to be 

reviewed. 

How will the data be used?

The data would allow the Agency to determine chronic effects, including effects on reproductive 

success and growth, to estuarine/marine fish from water column exposure to fluazinam. The effects 

data would be used to determine the likelihood that the chronic risks can potentially impact aquatic 

communities, either by direct effects on fish or by indirect effects on other organisms by reducing their 

food sources. 

How could the data change the Agency’s decision, or impact the Agency’s future decisionmaking? 

By conducting a chronic aquatic risk assessment, the Agency would be able to determine the potential 

risk to nontarget organisms. For endangered species risk assessments performed without these data, the 

Agency would have to assume that fluazinam "may affect" endangered fish directly (and endangered 

species from other taxa indirectly), and use of fluazinam might need to be restricted in areas where 

endangered species could be exposed. The lack of these data will limit the flexibility the Agency and 

registrants have in coming into compliance with the Endangered Species Act and could result in use 

restrictions for fluazinam, which are unnecessarily severe.
35

Guideline Number: 850.1350

Study Title: Aquatic Invertebrate Life-cycle (saltwater)

Rationale for Requiring the Data

A chronic study submitted for estuarine/marine aquatic invertebrates in response to the RED DCI was 

classified as supplemental. The chronic mysid study may be upgraded from supplemental if additional 

raw data is provided. 

Chronic studies on estuarine/marine organisms are required to support uses by which significant 

concentrations of a chemical are expected to enter into estuarine/marine environments. Persistence in 

water (e.g., half-life in water >4 days) can also trigger this data requirement. 

Practical Utility of the Data

How did the Agency make its re-registration decision without these data?

The previous assessment provided for a conditional registration while waiting for acceptable data to be 

reviewed. 

How will the data be used?

The data would allow the Agency to determine chronic effects, including effects on reproductive 

success and growth, to estuarine/marine invertebrates from water column exposure to fluazinam. The 

effects data would be used to determine the likelihood that the chronic risks can potentially impact 

aquatic communities, either by direct effects on invertebrates or by indirect effects on other organisms 

by reducing their food sources. 

How could the data change the Agency’s decision, or impact the Agency’s future decisionmaking? 

By conducting a chronic aquatic risk assessment, the Agency would be able to determine the potential 

risk to nontarget organisms. For endangered species risk assessments performed without these data, the 

Agency would have to assume that fluazinam "may affect" endangered invertebrates directly (and 

endangered species from other taxa indirectly), and use of fluazinam might need to be restricted in 

areas where endangered species could be exposed. The lack of these data will limit the flexibility the 

Agency and registrants have in coming into compliance with the Endangered Species Act and could 

result in use restrictions for fluazinam, which are unnecessarily severe.
36

Guideline Number: 850-1790

Study Title: Chironomid Sediment Toxicity Test 

Rationale for Requiring the Data

No Chironomid sediment toxicity test has been submitted to satisfy the Agency’s updated data 

requirements for outdoor uses in 40 CFR Part 158 (October 26, 2007). The lack of chronic 

estuarine/marine invertebrate toxicity data creates an additional layer of uncertainty for the potential 

effect of fluazinam on benthic organisms. Additional data has been requested to upgrade the 

supplemental classification for the chronic estuarine/marine invertebrate toxicity test to reduce the 

uncertainty associated with the use of fluazinam.

o Benthic organisms inhabit sediment environments that may be exposed to runoff or spray drift from fluazinam applications used in agricultural, forest, and 

residential settings

o The previous assessment identified a potential adverse effect for 

estuarine/marine aquatic organisms based on water column toxicity values. 

Therefore, there is uncertainty associated with that estimate that can be reduced 

using data from a toxicity test with benthic organisms. 

o Due to the potential for persistent exposure from fluazinam in sediment 

identified in the previous assessment, benthic organisms are exposed to 

fluazinam, which involves different routes of exposure for chronic exposure.

Practical Utility of the Data

How did the Agency make its registration decision without these data?

The agency estimated pore water EECs from PRZM/EXAMS using the equilibrium partitioning 

theory. An acceptable acute estuarine/marine aquatic invertebrate study was used to estimate RQs for the 

effect of fluazinam on benthic aquatic organisms in the previous assessment. A chronic 

estuarine/marine invertebrate study was also used to estimate RQs, but there is additional uncertainty 

due to the supplemental classification of the study. 

How will the data be used? 

Data from sediment toxicity studies will be used to estimate potential risks to benthic organisms

associated with uses of fluazinam. The data will reduce uncertainties associated with the current risk 

assessment for benthic species and will improve our understanding of the potential effects of fluazinam.

How could the data impact the Agency’s future decision-making?

Although there was uncertainty in estimating the effect of fluazinam on benthic organisms in the 

previous assessment, there was a potential risk associated with adverse effects identified for

estuarine/marine acute and chronic organisms. Acceptable data for benthic organisms will reduce the 

uncertainty from the previous assessment If the data indicates that registered fluazinam usage may pose 

a risk of adverse effects to non-target benthic organisms above the Agency Level of Concern, the 

Agency may explore decision options to mitigate this risk. The lack of these data will limit the 

flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act, 

and could result in use restrictions for fluazinam which may otherwise be avoided, or which are 

unnecessarily severe.
37

Guideline Number: 850.4150

Study Title: Vegetative vigor, Tier I/ Tier II

Rationale for Requiring the Data

No acceptable toxicity data are currently available to assess the risk of fluazinam to terrestrial plants. 

Since fluazinam has residential outdoor uses, vegetative vigor studies are required. These phytotoxicity 

data are needed to evaluate the level of pesticide exposure to non-target terrestrial and aquatic plants and 

to assess the impact of pesticides on endangered and threatened plants. 

Practical Utility of the Data

How did the Agency make its re-registration decision without these data?

Since EPA was unable to evaluate the potential risks to terrestrial plants associated with the proposed 

uses of fluazinam, risks were presumed for vegetative vigor endpoints for terrestrial plants.

How will the data be used? 

Data from terrestrial plant toxicity studies will be used to estimate potential risks to plants associated with 

uses of fluazinam. The data will reduce uncertainties associated with the current risk assessment for 

terrestrial plants and will improve our understanding of the potential effects of fluazinam on plants 

How could the data impact the Agency’s future decision-making?

Because plants form the basis of most habitats and significantly contribute to overall environmental 

quality, a solid understanding of the potential risks to terrestrial plants is essential for sound 

environmental management. Without acceptable plant growth data for fluazinam, the Agency cannot 

determine the levels of fluazinam that result in effects to terrestrial plants. If the data indicates that 

registered fluazinam usage may pose a risk of adverse effects to non-target terrestrial plants plants above 

the Agency Level of Concern, the Agency may explore decision options to mitigate this risk. The lack of 

these data will limit the flexibility the Agency and registrants have in coming into compliance with the 

Endangered Species Act, and could result in use restrictions for fluazinam which may otherwise be 

avoided, or which are unnecessarily severe.
38

Guideline Number: 850.4400*

Study Title: Aquatic Plant Growth-Lemna

Rationale for Requiring the Data

No acceptable studies have been submitted for vascular aquatic plants. Since the last risk assessment

was signed, the Agency has finalized its update to the data requirements in 40 CFR Part 158. In these 

updated data requirements, which were promulgated on October 26, 2007, vascular plant testing is 

required for pesticides such as fluazinam with outdoor uses.

Fluazinam is a fungicide and therefore EPA assumes it will affect aquatic plant species. 

Practical Utility of the Data

How did the Agency make its re-registration decision without these data?

Since EPA was unable to evaluate the potential risks to aquatic plants associated with the use of 

fluazinam, risks were presumed for vascular aquatic plants. 

How will the data be used?

Data from aquatic plant toxicity studies will be used to estimate potential risks to plants associated with 

uses of fluazinam. The data will reduce uncertainties associated with the current risk assessment for 

aquatic plants and will improve our understanding of the potential effects of fluazinam on vascular 

aquatic plants 

How could the data change the Agency’s decision, or impact the Agency’s future decisionmaking? 

Because plants form the basis of most habitats and significantly contribute to overall environmental 

quality, a solid understanding of the potential risks to aquatic plants is essential for sound 

environmental management. Without plant growth data for fluazinam, the Agency cannot determine 

the levels of fluazinam that result in effects to vascular aquatic plants. If the data indicates that 

registered fluazinam usage may pose a risk of adverse effects to non-target aquatic vascular plants 

above the Agency Level of Concern, the Agency may explore decision options to mitigate this risk. 

If future endangered species risk assessments are performed without these data, the Agency would have 

to assume that fluazinam "may affect" endangered plants and use of fluazinam might need to be 

restricted in areas where endangered species could be exposed. The lack of these data will limit the 

flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act 

and could result in use restrictions for fluazinam that may be unnecessarily severe. T
39

Guideline Number: 850.5400

Study Title: Aquatic plant toxicity test using Pseudokirchneriella subcapitata, Navicula pelliculosa

and Skeletonema costatum, Tier I 

Rationale for Requiring the Data

Although there is one acceptable study for aquatic nonvascular plants, Anabaena flos-aquae, no toxicity 

data are currently available to assess the risk of fluazinam to other aquatic nonvascular plants requested 

under the DCI. Since fluazinam has residential outdoor uses, Tier I aquatic nonvascular plant studies are 

required. These phytotoxicity data are needed to evaluate the level of pesticide exposure to non-target 

aquatic plants and to assess the impact of pesticides on endangered and threatened plants. 

Practical Utility of the Data

How did the Agency make its re-registration decision without these data?

Since EPA was unable to evaluate the potential risks to semi-aquatic plants associated with the proposed 

uses of fluazinam, risks were presumed for aquatic plants.

In making its decision, the Agency assumed that the required mitigation measures would reduce any 

potential risk of fluazinam to aquatic nonvascular plants.

How will the data be used? 

Data from Tier I nonvascular aquatic plant toxicity studies will be used to estimate potential risks to 

plants associated with uses of fluazinam. The data will reduce uncertainties associated with the current 

risk assessment for nonvascular aquatic plants and will improve our understanding of the potential effects 

of fluazinam.

How could the data impact the Agency’s future decision-making?

Because plants form the basis of most habitats and significantly contribute to overall environmental 

quality, a solid understanding of the potential risks to nonvascular aquatic plants is essential for sound 

environmental management. Without plant growth data for fluazinam, the Agency cannot determine the 

levels of fluazinam that result in effects to aquatic plants. If the data indicates that registered fluazinam

usage may pose a risk of adverse effects to non-target aquatic nonvascular plants above the Agency Level 

of Concern, the Agency may explore decision options to mitigate this risk. The lack of these data will 

limit the flexibility the Agency and registrants have in coming into compliance with the Endangered 

Species Act, and could result in use restrictions for fluazinam which may otherwise be avoided, or which 

are unnecessarily severe.
40

Appendix B. Ecological Toxicity Test Summaries

Birds

MRID 422486-22: Roberts, N.L., A. Anderson and I.S. Dawe (1991): An acceptable acute oral 

mallard duck (Ana platyrhynchos) toxicity study resulted in an LD50>4190 mg/kg/body weight. 

This indicates that fluazinam is practically nontoxic to birds. 

MRID 422486-23: An acute avian oral toxicity study resulted in an LD50=1782 mg/kg (1321-

3595 mg/kg) for the Bobwhite quail (Colinus virginianus). Nominal concentrations of 500, 100 

and 200 mg/kg were used to estimate the endpoint. This indicates fluazinam is slightly toxic to 

birds. Although only three treatment concentrations were used rather than five, this study was 

classified as core/acceptable.

MRID 422486-24: An acute avian dietary toxicity study resulted in an LC50>10,500 mg/kg for 

the Bobwhite quail (Colinus virginianus). Nominal concentrations of 313, 625, 1250, 2500, 

5000 and 10,000 mg/kg were used to estimate the endpoint. This indicates fluazinam is 

practically nontoxic to birds. This study was classified as core/acceptable.

MRID 422486-25: Roberts, N.L., A. Anderson and I.S. Dawe (1991): An acceptable acute 

dietary mallard duck (Ana platyrhynchos) toxicity study randomly assigned ten birds to six 

treatment and three control groups. An LC50>10,600 mg/kg was estimated from mean measured 

concentrations of 333, 651, 1260, 2590, 5230 and 10600 mg/kg. This indicates that fluazinam is 

practically nontoxic to birds. 

MRID 448073-23: An reproductive avian toxicity study resulted in a NOEC=200 mg/kg for the 

Bobwhite quail (Colinus virginianus). Nominal concentrations of 750, 1500 and 500 mg/kg for 

phase I and 50, 200, 350, and 500 mg/kg were used to estimate14 day old survivor weight, the 

most sensitive endpoint. This study was classified as core/acceptable.

MRID 448319-07: Beavers, J.B.; D. Haberlein, L.R. Mitchell and M. Jaber (1996).: An 

reproductive avian toxicity study resulted in a NOEC=200 mg/kg for the Bobwhite quail 

(Colinus virginianus). Nominal concentrations of 750, 1500 and 500 mg/kg for phase I and 50, 

200, 350, and 500 mg/kg were used to estimate14 day old survivor weight, the most sensitive 

endpoint. This study was classified as core/acceptable.

Terrestrial Invertebrates
41

MRID 422084-11: A 48 hour contact honey bee study resulted in an LD50>200 μg ai/bee. This 

indicates fluazinam is practically nontoxic to honey bees. There was no negative control used in 

this study. The study was conducted with a solvent control and mean treatment concentrations of 

20, 50, 100 and 200 μg ai/bee. This study was classified as core/acceptable.

Fish

MRID 429749-04: Gelin, M.D. and J. Laveglia (1992): A 96 hour acute rainbow trout 

(Oncorhynchus mykiss) study resulted in an LC50=36 μg/l based on mean measured 

concentrations. This study was classified as core/acceptable. This toxicity test indicates that 

fluazinam is very highly toxic to trout.

MRID 429749-05: A 96 hour acute bluegill study was conducted with a negative control, a 

solvent control and mean treatment concentrations of 21, 34, 44, 66 and 93 μg/l. The analysis 

resulted in an LC50=52.7 μg/l (47.1-59.9 μg/l). This study was classified as core/acceptable.

MRID 422084-09: A 96 hour acute rainbow trout (Salmo gairdneri) study was conducted with a 

negative control, a solvent control and mean treatment concentrations of 0.057, 0.064, 0.091,

0.16, 0.27 and 0.46 mg/L). The analysis resulted in an LC50-0.13 mg/l (0.10-0.18 mg/L). This 

study was classified as core/acceptable.

MRID 448073-27: An early life cycle fathead minnow (Pimephales promelas) study was 

conducted with a negative control, a solvent control and mean treatment concentrations of 1.6, 

2.7, 5.3, 10 and 23 μg/L). The analysis resulted in a NOEC=5.3 μg/L). This study was 

classified as core/acceptable.

MRID 448073-29: A 278 day fathead minnow (Pimephales promelas) was conducted with a 

negative control, a solvent control and mean treatment concentrations of 0.69, 1.4, 2.9, 6.4, and 

14 μg/L. The analysis resulted in a NOEC=0.69 μg/L. This study was classified as 

core/acceptable.

MRID 448073-25: Machado, M.W. (199 3).A 96 hour acute marine fish (sheepshead) was 

conducted with a negative control, a solvent control and mean treatment concentrations of 0.13, 

0.22, 0.36, .0.60 and 1.0 mg/l. No mortality was observed in the negative or solvent control. The 

analysis resulted in an LC50=0.12 mg/l (0.08-0.24 mg/l). This study was classified as 

core/acceptable. 
42

MRID 458221-02: Sousa, J.V. (2001). The chronic toxicity of IKF-1216 Technical (fluazinam) 

to the early life-stage of Sheepshead Minnow (Cyprinodon variegatus) was studied under flowthrough conditions for 35 days (7-day hatching period and 28-day post-hatch period). Fertilized 

embryos (160/treatment), 21- to 27-hours old, were exposed to IKF-1216 Technical at nominal 

concentrations of 0 (negative and solvent controls), 2.2, 4.4, 8.7, 17, and 35 ppb. Meanmeasured treatment concentrations were <0.18 (<LOQ, controls), 1.6, 2.8, 5.9, 12, and 26 ppb 

a.i., respectively. No treatment-related effects on embryo or larval survival, or on length and 

weight were observed. The NOEC for all endpoints was 26 ppb a.i., the highest concentration 

tested. A LOEC was not established.

Aquatic Invertebrates

MRID 429749-06: A 48 hour acute aquatic invertebrate (Daphnia magna) was conducted with a 

negative control, a solvent control and mean treatment concentration s of 34,54 94, 150 and 260 

μg/l. The analysis resulted in an EC50=220 μg/l (190-300 μg/l). This study was classified as 

core/acceptable.

MRID 422084-10: A 48 hour acute aquatic invertebrate (Daphnia magna) was conducted 

without a negative control, but with a solvent control and mean treatment concentration s of 0.06, 

0.13, 0.22, 0.38, 0.92 and 1.64 μg/l. The analysis resulted in an EC50=180 μg/l (140-220 μg/l). 

This study was classified as core/acceptable.

MRID 448073-28: A 21 day chronic freshwater invertebrate (Daphnia magna) was conducted. 

The flow through study used a negative control, a solvent control and mean treatment 

concentrations of 8.9, 16, 33, 68 and 140 μg/l. The analysis resulted in an NOAEC=68 μg/l for 

the most sensitive endpoints of dry weight and reproduction as total number of young per female. 

This study was classified as core/acceptable.

MRID 448073-26: A 96 hour acute estuarine/marine invertebrate (Mysidopsis bahia) was 

conducted. The flow through study used a negative control, a solvent control and mean 

treatment concentration s of 8.0, 13, 25, 40 and 70 μg/l. The analysis resulted in an LC50=39 

μg/l (34-45 μg/l). This study was classified as core/acceptable.

MRID 448073-24: A 96 hour acute marine oyster (Crassotrea virginica) toxicity test was 

conducted. The flow through study used a negative control, a solvent control and mean treatment 

concentration s of 0.84, 1.4, 2.6, 4.4 and 9.7 μg/l. The analysis resulted in an EC50=4.7 μg/l 

(3.6-6.0 μg/l). This study was classified as core/acceptable.

MRID 458221-01: Lima. W. (2002). In a 28-day life cycle test, Americamysis bahia neonates 

were exposed under flow-through conditions to IKF-1216 Technical (fluazinam) at nominal 

concentrations of 0 (negative and solvent controls), 0.25, 0.50, 1.0, 2.0, and 4.0 ppb. Meanmeasured concentrations were <0.054 (<LOQ, controls), 0.25, 0.52, 1.0, 2.0, and 3.9 ppb a.i., 

respectively. Prior to sexual maturity and pairing, there were 60 mysids/level. At Day 13, 20

pair/level were isolated for individual matings; the remainder of first-generation mysids were 
43

group retained. First-generation mysids were observed for mortality and signs of abnormal 

behavior once daily throughout the study. Once daily during the reproduction period, secondgeneration mysids were counted and discarded. Data endpoints included terminal percent 

survival of first-generation mysids (Day 28; combined sexes), number of young produced per 

female per reproductive day, and dry weight and length of surviving first-generation mysids 

(Day 28; gender-specific).

Plants

Terrestrial

MRID 461728-01. Stewart, P. (2003): An acceptable seedling emergence Tier I study (MRID 

461728-01) using the dicots cabbage, carrot, cucumber, lettuce radish, soybean and tomato and 

the monocots corn, oat, onion and ryegrass was received . The toxicity test resulted in an 

EC25>0.78lbs a.i./A based on no observed effects at the highest tested concentration. . 

Aquatic

MRID448073-34: A 96 hour freshwater algae (Selenastrum capricornutum) toxicity test 

analysis resulted in an EC50=180 μg/l (160-200 μg/l). This study was classified as supplemental 

due to a 96 hour versus 120 hour recommended duration. In addition, the light intensity

exceeded the recommendation. 

MRID 458221-06: Hoberg, J. (2002). In a 96-hour acute toxicity study, cultures of Anabaena 

flos-aquae were exposed to Fluazinam under static conditions at nominal concentrations 0 

(negative and solvent controls), 13, 25, 50, 100, and 200 ppb a.i. The initial measured 

concentrations were <0.88 (negative and solvent controls), 12, 26, 36, 72, and 140 ppb a.i. The 

initial measured concentrations were used instead of the 96 hour measured or means of the 0 and 

96 hour measured concentrations because the test material declined to <70% of nominal for both. 

The 96-hour cell density percent inhibitions based on the control were 19, 27, 10, 23, and 30% in 

the 12, 26, 36, 72, and 140 ppb a.i. treatment groups, respectively. Mean cell density was 

significantly reduced compared to the control for 140 ppb a.i. The cell density NOEC was 72 

ppb a.i. based on the Williams Test. The cell density EC50 was 9,200 ppb a.i. based on a 

Nuthatch analysis. This study was classified as acceptable.